Advanced Manufacturing Engineer

Location: Zuidland

Are you looking for a position where you are responsible for developing and improving assembly and testing processes for the manufacture of ophthalmic instruments and devices? Do you have knowledge and experience with international Medical Device regulations and standards? And are you always curious about new developments in your field? Then keep reading, we may have the perfect opportunity for you!

You will be held responsible for maintaining and improving current processes next to developing new processes for operations. You will collaborate closely with your colleagues from Manufacturing Engineering, Operations, R&D and Quality. New processes will be tested extensively, the data will be analyzed (DOE) and validated (IQ, OQ, PQ).

Responsibilities

Set-up risk analysis plans for assembly and test processes (pFMEA)

Design and improve assembly processes and implementation at the production floor (NPI)

Set User Requirements Specification

Use data analytics and simulation tools to test performance and optimize the process (DOE)

Validate assembly and test processes and/or specific equipment (FAT, SAT, IQ, OQ, PQ)

Analyzing and solving process problems with machines (RCA, DMAIC)

Setup preventive maintenance infrastructure (TPM)

Assessing design solutions for manufacturability (DFA, DFT)

Supervising and assessing 0-series and recording the results

Preparing production documents (assembly manuals)

Training and supervising production personnel and final inspectors in production

Reporting on progress of projects, hours spent, etc.

Knowledge and Experience

Regulations and standards in Medical Devices (ISO 13485, 21 CFR Part 820, EN ISO 11607-2, EN ISO 868-5, ISO 14971, etc.)

Familiar with clean room, cleaning and sterile barrier processes

Coordinating risk management activities (gathering stakeholders, writing pFMEA, etc.)

Setup of Design Of Experiments and familiar with data analysis software (Minitab)

Preparing and executing validation activities. Writing validation documentation (IQ, OQ, PQ)

Experience in coordination and planning of validation activities and aligning with stakeholders from different departments

Excellent written and oral communication skills in Dutch and English

A college education in a technical field such as Mechanical Engineering, or comparable level obtained through experience

At least 10 years' work experience in a position involving collaboration with multidisciplinary teams in a Medical Devices production environment

Benefits

27 holidays and 13 advance days for a 40‑hour full‑time job

8% holiday pay

13th month salary

Bonus scheme

Travel allowance of €0.23 per km

Non‑contributory pension leading to a higher net salary

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